Salami 1984.
Study characteristics | ||
Methods |
Allocation: randomised, but no further information Design: parallel‐group |
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Participants |
Number: 30 randomised Age: mean 46 (SD 4) Gender: 17 M, 13 F Setting: Italy Eligibility criteria: Ménière's disease, clinically defined Exclusion criteria: other causes of vertigo Baseline characteristics: groups similar at baseline |
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Interventions | Betahistine 8 mg 3 times a day versus placebo over 6 weeks Intervention group: n = 15 Comparator group: n = 15 Use of additional interventions: none |
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Outcomes | Primary outcome: vertigo intensity on a 4‐point scale Secondary outcomes: vestibular function tests (electronystagmography and caloric testing) | |
Funding sources | Not stated | |
Declarations of interest | Not stated | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomised"; no further information |
Allocation concealment (selection bias) | Unclear risk | Method not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, but no further information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double‐blind, but no further information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition (James 2001) |
Selective reporting (reporting bias) | Low risk | Outcomes and adverse events reported |
Other bias | Unclear risk | — |
AAO‐HNS: American Academy of Otolaryngology – Head and Neck Surgery BPPV: benign paroxysmal positional vertigo CNS: central nervous system ENG: electronystagmogram ENT: ear, nose and throat F: female M: male MD: Ménière's disease MS: multiple sclerosis SD: standard deviation